On July 23, the World Health Organization (WHO) declared monkeypox a global health emergency, and the United States is currently the world’s epicenter, with more than 6,600 cases across 48 states, the District of Columbia and Puerto Rico. And that is likely a significant undercount due to sporadic testing and underreporting. Most monkeypox cases are among men who have sex with men, but women and children have the disease as well. If we wait much longer to take urgent action, our country will be battling two pathogens novel to America — COVID-19 and monkeypox — for decades to come, severely straining the U.S. health system.
We need a national action plan now.
At last, Health and Human Services Secretary Xavier Becerra today declared monkeypox a national emergency. Such a declaration does not supplant the role of federal agencies or state health departments, but rather can help procure and marshal resources to effectively fight the disease. Monkeypox is a textbook case for an emergency declaration under Section 319 of the Public Health Service Act. Section 319 empowers HHS to make grants, enhance telemedicine, enter contracts, evaluate treatments, and unleash the nation’s public health emergency fund — all crucial for the resources, powers and flexibility needed to fight monkeypox.
Why did we wait so long, well after the WHO, California, Illinois and major cities like New York have sounded a public health alert? There were no downsides to declaring a public health emergency. There was no political opposition, and any legal challenges would be summarily dismissed.
Another important step forward is the president’s appointment this week of Robert Fenton as White House National Monkeypox Response Coordinator. Fenton is a trusted and experienced FEMA regional administrator with expertise in government and supply chain operations who will coordinate and communicate about the government’s multi-agency response, while working with the private sector. His deputy will be Dr. Demetre Daskalakis, director of the Division of HIV Prevention at the Centers for Disease Control and Prevention (CDC), with expertise in infectious disease management, including COVID-19, and health issues affecting the LGBTQ community.
Our flawed response thus far is due in no small measure to a fragmented public health system that lacks coordination and technological innovation. It is impossible to fight infectious disease outbreaks without essential data and effective communication about the disease, but that is exactly what is happening now. We need to collect national data that is accurate and disaggregated by age, gender, race/ethnicity and risk profile. It is unacceptable that the U.S. is currently unable to provide accurate assessments of key scientific factors needed to track and respond to monkeypox.
Think back over the last two years of COVID-19. We got our data on aerosolized spread, masks and vaccine and booster effectiveness from national health systems like those in the United Kingdom, Israel and South Africa. As the disease emerged, the CDC was late or missing in action regarding key data. The same thing is happening with monkeypox.
Since data drives policy, we must develop novel approaches to collecting this critical information in the absence of a seamless, standardized system of federal/state/local reporting. Currently, the CDC relies on state, tribal and local health departments for data, and there is no law that requires states and localities to share this vital information with the agency under our current system. The CDC recently designated monkeypox a nationally notifiable condition, but that still requires state cooperation.
Since 1992, in what is known as the “anti-commandeering” doctrine, the Supreme Court has ruled that the Tenth Amendment prohibits the federal government from forcing states to comply with federal dictates. Given constitutional barriers, novel 21st century data collection methods are urgently needed. A modern data ecosystem with innovative approaches should be established for monkeypox and other diseases so that critical data can be collected in real time, trends monitored efficiently, and forecasting models created.
Such a system could be built from signing long-term data use agreements with states and providing them with technical assistance and support. And while the CDC can’t compel states to share data, it could incentivize them by offering public health funding that is conditioned on their sharing this information. Data could also be gathered from federal sources such as Medicaid, Medicare and the Department of Veterans Affairs, open-source information like social media, and large hospital systems. Additionally, wastewater surveillance has proven highly effective in monitoring COVID-19 infection trends and should now be employed to measure monkeypox in communities across the country.
The reason we are so badly undercounting monkeypox cases is an inadequate testing infrastructure. While U.S. testing capacities have recently improved, there’s still much more to be done. With private laboratories now processing tests, U.S. capacity reached 80,000 tests last week, up from 6,000 tests a week at the beginning of the outbreak. However, the cost of tests is too high and getting a test result can be onerous. We need to make testing inexpensive and easy, including the development and distribution of at-home test kits if possible.
Finally, and most importantly, we must urgently increase supplies of, and equitable access to, treatment and vaccines. Although no therapies are currently authorized specifically for monkeypox, the federal government has medications in the national stockpile including over 1.7 million courses of tecovirimat, an antiviral that is FDA approved for smallpox. While the European Medicines Agency has authorized it for treating monkeypox, the drug is available in America only through an Expanded Access IND research protocol. That is far too laborious. By the end of June, only 300 courses of tecovirimat had been distributed from the stockpile. And while the FDA and CDC recently reduced the need to complete over 100 pages of paperwork to 20 pages, the agencies must go much further. Clinical trials are also needed to determine whether the drug can prevent disease if given as post-exposure prophylaxis.
Supplies of the FDA-authorized Jynneos monkeypox two-dose vaccine also remain under strain as demand skyrockets, leading to long lines at clinics and advocacy protests. The vaccine can be used for pre- and post-exposure prophylaxis. A decade ago there were 20 million doses of this vaccine in the national stockpile but they have expired, so there were just 2,400 usable doses available as the monkeypox outbreak emerged in America in May. While the government has purchased several million new vaccine doses, they will not be available until later this year and into 2023.
FDA Commissioner Dr. Robert Califf announced today that the agency is considering a “dose sparing strategy” to expand the vaccine supply but did not provide all of the scientific evidence behind this plan. With this proposed strategy, health care practitioners would be permitted to split a one-dose vaccine vial into five doses to be administered to five patients. The agency did not cite whether patients would be advised to return for a second dose 28 days following the first, as is the current practice.
Currently, the Danish-based biotechnology company Bavarian Nordic is the sole manufacturer of the monkeypox vaccines needed for Americans and the entire world. Since the Biomedical Advanced Research and Development Authority, an HHS agency, has contributed more than $1 billion as of 2014, with an estimated $2 billion total to date, in order to develop and produce this vaccine, it should rapidly determine whether this one company has adequate facilities in Denmark to produce enough vaccine now for all those who need it. A declared public health emergency enables the president to require or incentivize this company to contract with other vaccine manufacturers to help produce more vaccine at scale. The Defense Production Act could also help ramp up badly needed manufacturing capacity.
Mark Twain once said, “History never repeats itself, but it does often rhyme.” Let’s apply the lessons learned from the COVID-19 pandemic to ensure that there’s an innovative, effective action plan to contain monkeypox before it becomes endemic in America and worldwide.
Susan J. Blumenthal, MD, MPA, a retired rear admiral and former U.S. assistant surgeon general, is senior medical adviser at amfAR, The Foundation for AIDS Research, a senior fellow in health policy at New America, a clinical professor at Georgetown University School of Medicine and a visiting professor at the MIT Media Lab.
Lawrence O. Gostin, JD, is professor of Global Health Law at Georgetown University, where he directs the O’Neill Institute for National and Global Health Law. He is also director of the WHO Center of Global Health Law.
The authors wish to thank Emily Stark, a research associate in health policy at New America and an entering first-year law student at Boston College, for her contributions to this article.